After a long transitional period the Norm IEC 60601-1 with regard to safety requirements and ergonomical demands for medical devices has become effective as Version 3 on 1 June 2012. Specifically interesting in this new version is the topic risk management - especially because of the connection with the Norm EN 14971. The compliance with performance features as well as the functional safety have become more important now. In this respect the risk analysis can help to show risk minimisations.
As part of the design process the risk management process according to EN 14971 is also important for programmable electric medicinal products (PEMS). Furthermore, in addition to a life cycle a validation plan is also essential as part of the development.
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)